# K121590: Vestibular Analysis Apparatus

- Pathway: 510(k) (Traditional)
- Applicant: Capacity Sports, LLC
- Decided: Sep 20, 2012 after 112 days
- Product code: LXV (Apparatus, Vestibular Analysis)
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K911795 (1991). 2 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070676: Korebalance (Kinesthetic Ability Trainer), Sportkat, LLC (2007) Summary page 1.

## Most influential descendants
- K183661: ClearEdge Balance System (2019), 0 descendants of its own
- K190735: EQ Balance (2019), 0 descendants of its own
- K173669: K-D Balance (2018), 0 descendants of its own

## Indications for use
The Sway™ Balance System is intended for use to assess sway as an indicator of balance. Individual suitability for assessment must be judged on a case by case basis, by a qualified individual including those certified and/or licensed in their state to prescribe and/or use balance devices such as certified athletic trainers and coaches, physical therapists, nurses and physicians. Conditions affecting postural sway include nausea, headache, orthopedic injury, ear infection, medications, head injury, dehydration and fatigue. The Sway™ Balance System can be used wherever an iOS mobile operating device is available.

Source page: https://510kreport.com/device/K121590
Methodology: https://510kreport.com/methodology